Current through Register Vol. 51, No. 19, September 20, 2024
A. Primary Standard. A licensee shall
develop, establish, implement, maintain, and follow quality control policies,
procedures, and techniques that ensure accurate and reliable test results and
patient test reports.
B.
Standard-Quality Control Program. A licensee's quality control program shall:
(1) Cover all tests and related examinations
and procedures performed by the laboratory; and
(2) Meet the standards and requirements set
forth in this chapter.
C. Standard-Quality Control Practices. A
licensee's quality control practices shall include, but are not limited to, the
use of:
(1) Analyses of reference materials to
ensure that test results are:
(a)
Reproducible;
(b) Accurate;
and
(c) Reliable;
(2) Systems to ensure proper
functioning of:
(a) Instruments;
(b) Equipment; and
(c) Reagents;
(3) Validity, calibration, and systematic
procedural checks for:
(a) Reagents;
(b) Equipment; and
(c) Test systems; and
(4) Systems for:
(a) Review and reporting of test results that
ensure timely error detection and correction; and
(b) Assessment of laboratory personnel:
(i) Performance;
(ii) Proficiency; and
(iii) Competency.
D. Standard-Adequacy of
Methods and Equipment. A licensee shall:
(1)
Employ methods and equipment that provide accurate and reliable test results
and reports;
(2) Have sufficient
and suitable equipment and instruments to perform the type of testing services
and volume of tests offered by the laboratory;
(3) Monitor all test methods, instruments,
and test systems for the following performance characteristics, when
applicable:
(a) Detection limits for each:
(i) Method;
(ii) Instrument; and
(iii) Test system;
(b) Precision;
(c) Accuracy;
(d) Specificity;
(e) Sensitivity;
(f) Test interferences; and
(g) Other related test variables that affect
test results;
(4) Have
adequate systems in place to:
(a) Ensure that
a statistically valid number of counts or measurement levels are obtained and
verified to give accurate and reliable test results for systems each day
instruments and equipment such as cell counters, radiation counters, and
spectrophotometers are used; and
(b) Report results in an accurate and
reliable manner and within the time frames established by the laboratory;
and
(5) Perform test
methods and use instrumentation in a manner that permits the laboratory to
provide accurate and reliable test results within the laboratory's stated
performance criteria.
E.
Standard-Supplies, Reagents, and Materials. A licensee shall ensure that
supplies, reagents, and other materials used in the collection, handling,
testing, and storing of specimens in the laboratory are stored, labeled,
checked for proper reactivity, and used according to §§F-I of this
regulation.
F. Storage. A licensee
shall ensure that laboratory materials are stored in the manner stated by the
manufacturer.
G. Labeling. A
licensee shall ensure that laboratory testing materials, including reagents,
solutions, culture media, controls, and calibrators are labeled to indicate
the:
(1) Identity;
(2) Concentration, strength, or
titer;
(3) Storage
requirements;
(4) Preparation and
expiration dates;
(5) Identity of
the preparer; and
(6) Other
pertinent information that would affect test performance or outcome.
H. Reactivity Checks. A licensee
shall ensure that representative samples of each lot of materials used for or
in the process of testing specimens are tested on a regularly scheduled basis
to determine each material's capacity to perform as required.
I. Use of Supplies and Other Materials. A
licensee:
(1) May not use materials that have:
(a) Exceeded the material's expiration
date;
(b) Substandard reactivity;
or
(c) Deteriorated; and
(2) Shall use supplies, reagents,
kits, identification systems, and other materials in a manner consistent with
the recommendations and instructions provided by the manufacturer.
